SPECULAR MICROSCOPE CEM-530— 510(k) K130565

Substantially Equivalent

Nidek Co., Ltd.

FDA 510(k) clearance K130565 for SPECULAR MICROSCOPE CEM-530, Substantially Equivalent on 2013-11-27. Applicant: Nidek Co., Ltd..

Clearance details

Applicant: Nidek Co., Ltd.
Product code: Code NQE
Advisory panel: Ophthalmic
Date received: 2013-03-04
Decision date: 2013-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

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